A Randomised, Double-blind, Placebo-controlled 4-period Cross-over Study to Assess the Efficacy and Safety of Repeat Dose Intranasal GSK1004723 (1000µg), Oral GSK835726 (10mg) and Cetirizine (10mg) in the Environmental Challenge Chamber in Subjects With Seasonal Allergic Rhinitis
Overview
- Phase
- Phase 2
- Intervention
- GSK835726 10mg
- Conditions
- Rhinitis, Allergic, Seasonal
- Sponsor
- GlaxoSmithKline
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- •Males or female using contraceptives
- •Aged 18 - 65
- •Weight 50kg+, BMI 19-32 kg/m2
- •Exhibit response to Challenge Chamber and skin prick test.
- •Non-smoker
- •Capable of giving informed consent
- •AST and ALT\<2xULN; alkaline phosphatase and bilirubin \<or=1.5xULN
Exclusion Criteria
- •No nasal structural abnornmality/polyposis, surgery, infection.
- •any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- •participated in another clinical study within 30 days.
- •Subject has donated a unit of blood within 1 month
- •Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- •History of sensitivty to drug
- •History of alcohol/drug abuse within 12 months.
- •Positive Hepatitis B antibody test
- •Positive HIV antibody test
- •Risk of non-compliance with study protocol
Arms & Interventions
GSK835726 (10mg)
10mg oral dose
Intervention: GSK835726 10mg
GSK1004723 (1000mcg)
1000mcg nasal spray solution
Intervention: GSK1004723 1000mcg
Cetirizine 10mg
10mg cetirizine as active comparator
Intervention: Cetirizine 10mg
placebo
placebo
Intervention: placebo
Outcomes
Primary Outcomes
Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
Time Frame: Day 3 of each treatment period (approximately up to 63 days)
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.
Secondary Outcomes
- Mean Forced Expiratory Volume in 1 Second (FEV1)(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(approximately up to 63 days)